Project Validation Specialist

For Project Validation services in the Facilities areas.

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s Degree in Engineering or Science and at least six (6) years of exposure to Validation Engineering activities within the Pharmaceutical or Medical Devices industry. 
• Strong project management skills with experience leading complex, cross-functional initiatives
• Bilingual (Spanish and English)
• Shift: Administrative & according to business needs 
• Experience in:
  • Facilities & Utilities Validation 
  • FDA, OSHA, EPA, GMPs, ISO standards, and GAMP 5; strong understanding of Computer Systems Validation Life Cycle and regulatory guidelines. 
  • Generating validation documentation including URS, FRS, SDS, traceability matrices, and IQ/OQ/PQ protocols.
  • Organizational Excellence, Lean, and Six Sigma methodologies. 

The Personality Part:    

• Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients and team members. In other words, being a customer service pro is one your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to take on this new challenge?

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

• Plans, develops, and implements documentation, procedures, and training necessary for the engineering team.
• Actively participate in the Validation Life Cycle of regulated projects by reviewing validation documentation, participating in application requirements definition, risk assessments, traceability matrix, validation protocol development, validation testing, and deviation management.
• Generation of validation plans, User Requirement Specifications (URS), Functional Requirement Specifications (FRS), System Design Specifications (SDS), traceability matrix, as well as development and execution of validation protocols (FAT/SAT/IQ/OQ/PQ), and completion reports.
• Develop statistically based sampling plans for in-process and final testing and inspections, and validations.
• Review and approve validations and completion reports for new and existing computer and automation systems.
• Evaluate, investigate and document non-conformances incidents and/or protocol deviations.
• Complete assigned Non-Conformance and CAPA investigations and prepare investigation reports.
• Manages and supervises the installation of equipment and controls/software modifications for automated equipment.
• Lead process improvement projects to improve the validation of computerized systems.
• Assure that existing processes and assigned activities fully comply with regulatory and/or international agencies, such as FDA, ISO, OSHA, EPA, among others.

WHO WE ARE:

We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS! 

Are you the Next Piece?